The Food and Drug Administration’s active surveillance system designed to search health data to uncover adverse safety events for newly approved drugs is coming under fire from critics who say that progress is coming too slowly.

Aaron Kesselheim, M.D., a health policy researcher in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women’s Hospital in Boston and an Assistant Professor of Medicine at Harvard Medical School, believes the FDA’s Sentinel system is promising, but says the jury is still out on whether the regulatory agency will in fact succeed in achieving its goal.

“The problem is that the essential work in the Sentinel system of distinguishing the signal of the safety event from the noise of everything else that’s going on with a drug in the post-approval observational setting is really very, very hard,” Kesselheim  told a July 9 congressional hearing. “In the last six or seven years, the Sentinel initiative has been focused on the methods used to try to do this and has made relatively slow, steady, little progress in trying to assess these kinds of methods.”     

As proof, he added that the FDA “itself still refers to the Sentinel initiative as the Mini-Sentinel pilot program now six or seven years out from its creation.” Mini-Sentinel is leveraging electronic healthcare data--principally claims data but also including data from EHRs--to monitor the safety of FDA-regulated medical products.

According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, theMini-Sentinel system can survey more than 350 million person years of observation, 4 billion pharmaceutical dispensings, and 4.1 billion patient encounters.

Woodcock testified July 11 before a congressional hearing thatSentinel uses pre-existing electronic health care data from 18 data partners, capturing information on more than 150 million patient lives. Eighteen large healthcare organizations from across the United States, including Aetna, Humana and Kaiser Permanente, are serving as data partners for Mini-Sentinel.

However, Kesselheim warns that there is “still much, much more to be done before we can rely on the Sentinel initiative for any sort of real active surveillance and I think that that’s far in the future.”

“My understanding is that the funding of the Sentinel initiative going forward is still up in the air. So, I would encourage Congress to continue to fund it. But, I would also not get peoples’ hopes up that the Sentinel system is going to be some white knight from a post-market surveillance point of view,” he said.


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